In today’s drug development world it still amazes me to find companies that don’t have an overall drug develop life cycle plan in place, especially when there is a baseline tool endorsed by FDA that could be used. In March 2007, the FDA released a draft guidance entitled, “Guidance for Industry and Review Staff Target Product Profile – A Strategic Development Process Tool”. The Target Product Profile (TPP) template format described in the guidance is a summary of a drug development program presented in terms of labeling concepts. The guidance describes the purpose of a TPP, its advantages, and its optimal use. It also provides guidance on how to complete a TPP and relates case studies that demonstrate its usefulness.
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